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The impurities typically found in Tenofovir include related substances, such as process-related impurities and degradation products.
The impurities in Tenofovir are analyzed using high-performance liquid chromatography (HPLC), which separates the impurities from the drug substance and quantifies their concentrations.
The impurities in Tenofovir are removed, through various purification methods, such as crystallization and column chromatography. The extent to which the removal of impurities depends on their chemical properties and concentration.
Tenofovir impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
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